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FASD Prevention R33 (R33)

14 de septiembre de 2026 actualizado por: Yukiko Washio, Philadelphia College of Osteopathic Medicine

Adapting and Testing Behavioral Intervention to Prevent Fetal Alcohol Spectrum Disorders and Adverse Infant Outcomes (R33)

This R33 application proposes to adapt and test an evidence-based behavioral intervention to decrease polysubstance use (i.e., alcohol and tobacco/cannabis) during pregnancy and lactation and prevent adverse clinical outcomes, including fetal alcohol spectrum disorder (FASD) in South Africa (SA). SA has a long history of social and health disparities, resulting in the world's highest rate of FASD (111.1 per 1,000), where lifelong negative cognitive and physical effects result from prenatal alcohol exposure. FASD is completely preventable if women do not drink during pregnancy. Prenatal alcohol use frequently co-occurs with other substance use, especially tobacco and cannabis. The adverse effect on birth outcomes by alcohol and tobacco use together is worse than either substance alone. Recent evidence from animal models shows that prenatal exposure to both cannabinoids and alcohol potentiate the likelihood of alcohol-induced birth defects. Data from Cape Metropole, SA, showed that all women who reported prenatal alcohol use also tested positive for tobacco use, with 25% also reporting cannabis use. Alcohol use while breastfeeding also occurs at a relatively high rate in SA. Despite tremendous health benefits from breastfeeding, maternal alcohol use while breastfeeding significantly compromises infant development. Contingency management (CM) has been efficacious in reducing prenatal cocaine, alcohol, and tobacco use in the United States (U.S.). The Women's Health CoOp (WHC) is an evidence-based brief intervention addressing women-focused syndemic issues and resulting disparities associated with substance and alcohol use. These evidence-based interventions need to be combined and adapted for addressing maternal polysubstance use and associated health and behavioral issues during pregnancy and lactation in SA.

Descripción general del estudio

Estado

Aún no reclutando

Tipo de estudio

Intervencionista

Inscripción (Estimado)

184

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Yukiko Washio, PhD
  • Número de teléfono: (215) 871-6100
  • Correo electrónico: yukikowa@pcom.edu

Ubicaciones de estudio

      • Cape Town, Sudáfrica
        • University of Cape Town
        • Contacto:
          • Heather Jaspan, MD, PhD
          • Número de teléfono: +27 21 650 9111
          • Correo electrónico: hbjaspan@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • (1) be pregnant, (2) intend to breastfeed, (3) test positive for alcohol use by urinalysis (i.e., EtG), (4) test positive for tobacco or cannabis use by urinalysis (i.e., cotinine and THC), (5) have an independent access to a mobile phone, (6) plan to remain in the area during pregnancy and 3 months postpartum.

Exclusion Criteria:

  • Report serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Usual Care
Participants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back. R200 will be provided for sample provision. Research staff will make referrals to treatment programs in the community as needed.
Participants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back. R200 will be provided for sample provision. Research staff will make referrals to treatment programs in the community as needed.
Experimental: Intervention
Participants will receive text-based support on health promotion and referral content based on educational components. Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.
Participants will receive text-based support on health promotion and referral content based on educational components. Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Urinalysis results for alcohol use
Periodo de tiempo: From enrollment to the end of treatment at 3 months postpartum
An alcohol metabolite (EtG) will be measured in urine samples. EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days after light drinking with ≥150 ng/mL for EtG as a cutoff value.
From enrollment to the end of treatment at 3 months postpartum
Urinalysis results for tobacco use
Periodo de tiempo: From enrollment to the end of treatment at 3 months postpartum
Biochemical verification of recent tobacco use in urine samples. A tobacco metabolite (cotinine) will be measured in urine samples. The metabolite can be detected up to 3-4 days after use with ≥ 80ng/mL as a cutoff.
From enrollment to the end of treatment at 3 months postpartum
Urinalysis results for cannabis use
Periodo de tiempo: From enrollment to the end of treatment at 3 months postpartum
Biochemical verification of recent cannabis use in urine samples. A cannabis metabolite (THC) will be measured in urine samples. The metabolite can be detected up to 28 days after heavy use with ≥50 ng/mL as a cutoff.
From enrollment to the end of treatment at 3 months postpartum

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Birth weight
Periodo de tiempo: Birth
Birth weight
Birth
Gestational age at birth
Periodo de tiempo: Birth
Gestational age at birth
Birth
Head circumference
Periodo de tiempo: Birth
Head circumference
Birth
Apgar score
Periodo de tiempo: Birth
Apgar score
Birth
NICU admission
Periodo de tiempo: Birth to 3 months postpartum
NICU admission and length of stay
Birth to 3 months postpartum
Infant weight at 3 months
Periodo de tiempo: 3 months postpartum
Infant weight at 3 months
3 months postpartum
Infant height at 3 months
Periodo de tiempo: 3 months postpartum
Infant height at 3 months
3 months postpartum

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de febrero de 2027

Finalización primaria (Estimado)

31 de enero de 2029

Finalización del estudio (Estimado)

30 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

11 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Publicado por primera vez (Actual)

18 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

A limited data set in which names and other personal health identifiers are removed will be supplied to researchers on request. The data will be made available after the publication of the study results. Analytic files will be collected in Redcap and then prepared in SPSS, R, SAS, or STATA, with online codebooks giving the variable name, label, type, format, positions, consistency codes, and, if applicable, values and value labels. Requesting access to data will involve drafting an abstract, checking the feasibility relative to the available data, and then seeking the permission of the principal investigator and the team for review, if appropriate. The data sets will be ready for use and can be converted to other analytic tools.

Marco de tiempo para compartir IPD

After study outcomes are published for 3 years

Criterios de acceso compartido de IPD

those with the permission of the principal investigator and the team investigators

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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